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This will be a multi-center, randomized, blinded, comparative, placebo-controlled, 4 arm crossover study in patients with primary insomnia.
Prospective patients will spend 2 nights in the sleep lab for baseline PSG assessments. Those who meet the protocol inclusion/exclusion criteria will return for four treatment periods with two consecutive nights in each. Study medication will be administered in the sleep laboratory 30 minutes before the patient's usual bedtime.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | adipiplon 6 mg |
|
| 2 | Experimental | adipiplon 9 mg |
|
| 3 | Placebo Comparator | Placebo |
|
| 4 | Experimental | Ambien CR 12.5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adipiplon | Drug | bilayer tablets 6 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The study will involve PSG measurement of sleep onset and maintenance. | two consecutive nights on each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The study will involve subjective measures of sleep and next day function. | two consecutive nights on each treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Broward Research Group | Pembroke Pines | Florida | 33026 | United States | ||
| Miami Research Associates |
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| Drug |
Placebo |
|
| Ambien CR | Drug | Ambien CR 12.5 mg |
|
| Adipiplon | Drug | bilayer tablets 9 mg |
|
| South Miami |
| Florida |
| 33143 |
| United States |
| Neurotrials Research, Inc | Atlanta | Georgia | 30342 | United States |
| Sleep and Behavior Medicine Institute | Vernon Hills | Illinois | 60061 | United States |
| Vince & Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| St. Luke's Hospital Sleep Medicine and Research Center | Chesterfield | Missouri | 63017 | United States |
| Clinilabs, Inc. | New York | New York | 10019 | United States |
| Tri-State Sleep Disorders Center | Cincinnati | Ohio | 45246 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C568848 | adipiplon |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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